Quality and regulatory compliance is crucial for 3D printing in healthcare as it ensures safety, efficacy, and reliability of the technology, ultimately benefiting the patient. Consistent, high-quality 3D-printed products foster trust in the product leading to increased adoption. My role as a Clinical Applications Specialist allows me to learn about how various institutions approach quality management in 3D printing at the point of care. 3D lab managers are often overwhelmed with tasks as they are asked to be a Jack of all trades – salesman, engineer, technician, quality manager, project manager, and accountant. The FDA has not yet formalized guidance around 3D printing at the point of care, only releasing a discussion paper to date with proposed scenarios for regulation. So, 3D lab managers are trying to fit quality into their workflow without a cemented policy to use for framework.
As a commercial medical device manufacturer, Ricoh 3D for Healthcare registers all its production facilities with the FDA whether at the point of care, such as our Healthcare Innovation Studio at Atrium Health Wake Forest Baptist, or an offsite facility like our centralized production facility in Ohio. Ricoh 3D holds high-quality standards for its patient-specific, 3D printed devices, like anatomic models, and employs an FDA compliant and ISO 13485 certified Quality Management System (QMS). All anatomic models products undergo rigorous inspection, including a digital scan showing sub millimeter accuracy to the digital file. Processes and equipment are validated in accordance with international standards and relevant guidance documents prior to their use in production. Our engineering and production teams also adhere to work instructions and are rigorously trained in the design and production process of anatomic models. The model ordering platform is HIPAA-compliant and saves only the necessary data for traceability. All these processes are diligently documented for traceability and risk management. This applies to any medical device Ricoh 3D creates or will produce including the new oral stent device from Kallisio.
While the previously listed processes are not all-encompassing, they are core to Ricoh 3D’s delivery of high-quality anatomic models. Surgeons have utilized these anatomic models for pre-surgical planning, leading to decreases in operative time[1] and improved patient understanding[2]. Our QMS ensures that the surgeon can be confident utilizing the anatomic models accurately in surgical planning such as pre-sizing implants or mapping out areas for resection.
Adherence to guidelines and standards also provides more credibility for a device to be reimbursed by insurance. Currently, there is little to no reimbursement of patient-specific, 3D-printed anatomic models and they only possess Category III CPT billing codes that are temporary and utilized more for tracking usage than reimbursement. This is a major concern for hospitals and clinicians wanting to adopt 3D printing technologies, especially for anatomic models.
Insurance companies consider many factors in deciding whether to reimburse a medical device or not. One is its regulatory status. Ricoh 3D has FDA-clearance for their patient-specific anatomic models, but many point-of-care printing labs do not. Other considerations are clinical evidence and outcomes. Many point-of-care printing labs run small-scale studies demonstrating clinical outcomes such as reduced operative time and changes in surgical approach. Because Ricoh 3D is a commercial manufacturer of FDA-cleared anatomic models, we have partnered with Stratasys, Ltd. to run a first-of-its-kind randomized controlled clinical trial.
The trial is focused on anatomic model use in presurgical planning for bony tumor procedures in subjects aged 13+. The primary result we are hoping to see is a reduction in operative time. Other endpoints include a reduction in blood loss, positive margins, and adverse events. Insurance companies will recognize these outcomes as a cost-effective application of anatomic models, as they contribute to reducing costs per patient. This study is expected to conclude at the end of 2025, and we are hopeful that it will result in Category I CPT codes.
While quality and regulatory measures are extremely important to newer technologies like 3D-printed medical devices to ensure patient safety, they are also important in instilling trust in a product to increase its utilization. That increased trust also leads to more reimbursement as insurance companies view 3D-printed medical devices as a net positive to their business, reducing costs and improving patient outcomes. Ricoh 3D for Healthcare aims to lead in producing high-quality 3D-printed medical devices and seeks to expand its offerings to advance healthcare, one 3D-printed device at a time. The future is bright for 3D-printing in healthcare!
For more information on Policy for Additive Manufacturing in Healthcare, check out Lexi Gormley as she presents at Additive Manufacturing Strategies 2025 in February https://additivemanufacturingstrategies.com/.
[1] Ballard DH, Mills P, Duszak R Jr, Weisman JA, Rybicki FJ, Woodard PK. Medical 3D Printing Cost-Savings in Orthopedic and Maxillofacial Surgery: Cost Analysis of Operating Room Time Saved with 3D Printed Anatomic Models and Surgical Guides. Acad Radiol. 2020 Aug;27(8):1103-1113. doi: 10.1016/j.acra.2019.08.011. Epub 2019 Sep 18. PMID: 31542197; PMCID: PMC7078060.
[2] Sanchez AU, Dos Anjos GQ, de Oliveira DGC, Lima JA, de Lira MS, Costa Júnior MA, de Almeida MBV, Heilmann RM, Rolim Filho EL. Impact of 3D-Printed Anatomical Models on Doctor-Patient Communication in Orthopedic Consultations: A Randomized Clinical Trial. Cureus. 2024 Oct 4;16(10):e70822. doi: 10.7759/cureus.70822. PMID: 39493008; PMCID: PMC11531919.
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